510(k) K153210

Defibrillator Analyzer Variable Load by Bc Group International, Inc. — Product Code DRL

K153210 is an FDA 510(k) premarket notification submitted by Bc Group International, Inc. for the device "Defibrillator Analyzer Variable Load". The FDA issued a decision of Substantially Equivalent on December 21, 2015. The device falls under product code DRL (Tester, Defibrillator), a Class II device regulated under 21 CFR 870.5325. Bc Group International, Inc. has at least 1 other 510(k) clearance on record.